MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2, 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been received by the manufacturer for evaluation.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.
Event or Problem Description
It was reported during use picc flushed and fracture noted.No other information was provided.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of a leak along the catheter shaft is confirmed, but the root cause could not be determined.One 4 fr s/l powerpicc solo was returned for evaluation.An initial visual observation of the returned catheter revealed blood use residues throughout the returned device.A functional test of pressurizing the catheter with water using a 12 ml syringe revealed a leak at the 7 cm depth marker.A microscopic observation of the split observed at the 7 cm depth marking revealed a longitudinal split at a slight angle with uneven fracture edges.The fracture surface appeared granular with no evidence of striations.The split was not observed to be along the knit line of the catheter extrusion.No evidence of kinking was observed along the catheter; however, some tensile, or pulling weakness was observed along the catheter shaft between the 5 cm and 8 cm depth markings.Additional factors such as compressional and/or torsional forces may have contributed to the observed damage, but a root cause could not be determined for this failure.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO2, 3CG
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21971691
• Report Number: 3006260740-2025-02871
• Device Sequence Number: 8350954
• Product Code: LJS
• UDI-Device Identifier: 00801741185021
• UDI-Public: (01)00801741185021(11)240610(17)250731(10)REJQ1504
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: CK000267A
• Device Lot Number: REJQ1504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown